The use of single use bags and other biocontainers is growing in the pharmaceutical and biopharmaceutical business. These bags replace stainless tanks, totes and bins for the processing and transportation of liquids and solids such as raw materials, intermediates and finished goods.
Such film are typically multilayered plastic film structures. They are typically laminates of 4 or more layers (generally between 4 and 10 layers). They generally have 3 or more zones or layers, an inner contact zone which is in contact with the liquid within the bag and which is one or more layers of a generally inert material such as polyethylene that is not likely to release extractables, such as oils or fillers into the content of the bag; an intermediate zone, which often has one or more gas impermeable layers such as ethylene vinyl acetate (EVA), polyethylene vinyl alcohol (EVOH), and the like; and an outer strength zone which provides support, burst resistance and some measure of protection to the remaining zones of the biocontainer and which is generally formed of one or more layers of plastics such as polyethylene, polypropylene, polyethylene-vinyl acetate (EVA), polyethylene teraphthalate (PET), polyamide (nylon), and the like.
Biocontainers are generally inspected and gross leak tested for defects before they are shipped to the user, however, current films in biocontainers lack the strength, toughness and durability to survive the multiple manipulation steps used in atypical biotech facility to unpackage, install and use such a biocontainer. Due mostly to operator handling there is still the chance for a cut, puncture or abrasion to occur to the biocontainer. This can lead to not only loss of the biocontainer but also of its contents which in the case of pharmaceuticals especially biopharmaceuticals represents a significant monetary loss.
What is needed is a new biocontainer and film for biocontainers which is resistant to cuts, punctures and abrasions.